India needs to tackle regulatory delays and introduce “comprehensive and ongoing” training of clinical investigators if it is maximise the country’s potential as a destination for international clinical trials, the results of a recent survey suggest.

Dr Rakesh Parikh and colleagues from local site management organisation Dr Clinarch asked stakeholders from the clinical trial industry in India – largely clinical research co-ordinators and clinical research associates – for their perceptions of the current growth trend in clinical research, whether the industry was realising its full potential, the performance of investigator sites and regulators in India, training provision, and hurdles to future growth.

The results were published in the July-September edition of Perspectives in Clinical Research. Among the 181 survey respondents, 77.3% felt the clinical trial industry in India was growing while 13.8% believed that growth had plateaued and 7.7% that the industry was now in decline. Only 21.5% of the respondents said India was exploiting its full potential in clinical research.

On a scale of 1-10, the mean score for investigator site performance was 5.5 while corresponding figures for the performance of site management organisations/contract research organisations/trial sponsors and of regulatory bodies were 6.5 and 5.0 respectively. Stakeholder training standards in clinical research earned an average score of 5.6.

Regulatory delays

In terms of growth hurdles, the issue most cited was delays in regulatory approvals, followed by lack of trained investigators, lack of awareness among the general public, unethical practices and shortages of trained staff.

Other hurdles mentioned by the survey respondents included the functioning of ethics committees, the “clinician mindset” of investigators, high investigator fees and an over-emphasis on financial gain, ignorance of Indian pharmaceutical companies and a lack of authentic source records, Parikh et al reported.

If investigator mindsets are to change – an issue raised by most of the respondents – then “we will need to have comprehensive and ongoing training of investigators”, they suggested.

Currently, training in clinical research “is largely limited to attending the investigators’ meetings, which mainly focus on the particular protocol”. As such, investigator involvement in organisations such as the Indian Society for Clinical Research and active participation in the Society’s various activities “would surely be of great help”.

The industry should also pay more attention to the continuing training of its employees  and should extend that effort to team members at investigator sites “so as to train them on broader issues like ethics and basics of ICH GCP [International Conference on Harmonisation Good Clinical Practice standards]”, Parikh et al said.

As far as the regulatory system was concerned, any changes would have to come from government but “stakeholders like us can surely take efforts in bringing these issues and their repercussions to the notice of concerned authorities”, they added.